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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 205983

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NDA 205983 describes QUETIAPINE FUMARATE, which is a drug marketed by Accord Hlthcare, Alignscience Pharma, Amneal Pharms, Aurobindo Pharma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Novast Labs, Ph Health, Pharmadax Inc, Prinston Inc, Rising, Sciegen Pharms, Unichem, Actavis Grp Ptc, Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Jubilant Generics, Pharmobedient, Sun Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in thirty-eight NDAs. It is available from forty-eight suppliers. Additional details are available on the QUETIAPINE FUMARATE profile page.

The generic ingredient in QUETIAPINE FUMARATE is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 205983

Tradename:	QUETIAPINE FUMARATE
Applicant:	Ipca Labs Ltd
Ingredient:	quetiapine fumarate
Patents:	0

Medical Subject Heading (MeSH) Categories for 205983

Antipsychotic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	May 20, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	May 20, 2024	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	May 20, 2024	TE:		RLD:	No

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